Rising On Good News and Bad: Human Genome Sciences (NASDAQ:HGSI) |
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By M.E.Garza | |
Thursday, 04 June 2009 04:07 | |
HGSI has three products in late-stage clinical development: Albuferon for chronic hepatitis C, LymphoStat-B for systemic lupus erythematosus and ABthraxtm for inhalation anthrax. Both Albuferon and LymphoStat-B are progressing toward commercialization. As listed in BiomedReports' FDA Decisions Calendar, and tracked via our FDA Calendar Updates, HGSI announced (on 5/21/09) that it submitted a Biologics License Application (BLA) to the FDA for its human monoclonal antibody drug ABthrax (raxibacumab). Raxibacumab is a first-in-class treatment for anthrax, and is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services (HHS).
The stock price was no doubt helped by yesterday's awful news that al Queda terrorists are planning a biological weapons attack against the United States. "What a horrifying idea; 9/11 will be small change in comparison. Am I right? There is no need for airplanes, conspiracies, timings and so on. One person, with the courage to carry 4 pounds of anthrax, will go to the White House lawn, and will spread this 'confetti' all over them, and then we'll do these cries of joy. It will turn into a real celebration." The company's balance sheet, which looks good, might be helped by these dark developments as the have been developing the ABthrax, or raxibacumab drug for emergency use in just such a scenario. Human Genome Sciences delivered 20,000 doses of the drug to the U.S. Strategic National Stockpile in the first quarter. The company will receive $10 million from the U.S. government if the FDA approves the drug, but that isn't the only thing that has investors buzzing. The company believes that LymphoStat-B could become a breakthrough treatment for Systemic Lupus Erythematosus, or SLE, if the positive results of the phase II trials are confirmed in Phase III trials which were designed directly with input and consultation from the FDA and in partnership with GlaxoSmithKline (NYSE:GSK) under a co-development and commercialization agreement. The trials have enrolled 810 patients and results of the studies are expected in July and November of this year. An estimated 1.5 million Americans and nearly five million people worldwide suffer from lupus. The federal government, the pharmaceutical and biotechnology industries are the largest sources of funding for lupus research, but the search for a cure has not yielded very good results in the past. As a matter of fact, 50 years have passed since the FDA approved a drug for lupus- a disease in which the body's immune system attacks its own cells and tissues, damaging the organs and affecting various body parts, including joints, skin, blood, and kidneys. Human Genome Sciences also has substantial financial rights to two drugs that GlaxoSmithKline has advanced to late-stage development. In December 2008, GSK initiated the first Phase III clinical trial of Darapladib for chronic coronary heart disease. Darapladib was discovered by GSK based on Human Genome Sciences technology. A second large Phase III trial of Darapladib is expected to begin in late 2009. In February 2009, GSK initiated a Phase III clinical trial of Syncria in the long-term treatment of type 2 diabetes mellitus. Syncria was created using Human Genome Sciences' proprietary albumin-fusion technology, and was licensed to GSK in 2004. The company has seen shares trading in the range of $0.45 - $8 for the past twelve months and is definitely worth keeping an eye on. ![]() [WhatsTrading.Com reports that HGSI is attracting very bullish option action attention-- 6,500 calls traded, compared to 170 puts]
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